K120353
Substantially EquivalentSYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
- Applicant
- Bm Korea Co., Ltd.
- Product code
- MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fullerton, CA, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.